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Clinical Trial Summary

This trial will address the impaired quality of life of young people with asthma, despite appropriate medicines. Research shows that young people report needing to calm themselves down during an asthma attack to control their breathing. Although physiotherapist- delivered breathing retraining programmes now have a clear evidence base in adults with asthma, improving quality of life, there is a lack of evidence assessing its use in younger patients. The investigators have redesigned an adult training package to make it appropriate for young people and will now assess how effective such an intervention would be in this population. This study will include young people (12-17 years) with physician diagnosed asthma. The repurposing, optimisation and acceptability of the intervention in the adolescent age group has been undertaken in Stages 1 and 2 of the BREATHE4T project. A self-guided, breathing retraining digital intervention has been developed, delivered via a mobile friendly, online platform. The current study is a randomised, controlled feasibility trial and will provide the necessary information for a substantive cost-effectiveness trial. Participants with access to the intervention will be compared to a usual care group. Asthma and quality of life of both groups will also be assessed at baseline, 2-month and 6-month time points. At the end of the 6 months, the control group will also be given access to the website. The online nature of this study allows recruitment from across the UK. Recruitment methods would include primary care, hospital clinics, social media and posters. Asthma UK will also provide publicity to assist recruitment.


Clinical Trial Description

The trial will aim to assess the acceptability, uptake and success in collecting follow up data and variance in asthma-related outcome measures. A parallel group design will be used with participants being randomised to intervention or normal management. The intervention will be a self-guided, breathing retraining digital intervention, delivered via a mobile-friendly, online platform. The intervention will continue to be used for 6 months after which both groups will be reassessed. The usual management control group will then have access to the intervention (delayed access). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05006703
Study type Interventional
Source University of Southampton
Contact
Status Completed
Phase N/A
Start date June 22, 2021
Completion date September 30, 2022

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